Who wants to read something not related to COVID? I have a new paper out today with SACHRP chair, Stephen Rosenfeld, on IRB quality and the challenges of different board structures and ownership models. 1/ https://www.acpjournals.org/doi/10.7326/M20-1674

This piece was prompted by an inquiry from Sens. Warren, Sanders, and Brown to Advarra and WCG Clinical back in the fall raising concerns about for-profit models and private equity ownership in particular (as well as concerns about pay-to-play trials). 2/ https://www.warren.senate.gov/oversight/letters/senators-warren-brown-and-sanders-investigate-inherent-conflicts-of-interest-of-private-equity-owned-institutional-review-boards

The inquiry asked a lot of questions about how these boards evaluate their own quality and effectiveness, which is exactly what http://www.AEREO.org  is interested in (for all boards). 3/

Dissatisfied with the answers, senators have called for a GAO investigation into whether “existing standards of quality, efficiency, and effectiveness provide adequate protection for participants in IRB-approved clinical trials,” among other things. 4/ https://www.warren.senate.gov/imo/media/doc/2020.06.16%20Letter%20to%20GAO%20request%20on%20for-profit%20IRBs%20.pdf

Concerns about for-profit boards aren’t new (see the early 2000s). And there are also concerns about academic models. Lots of pressure to speed things up, avoid “mission creep,” just stick to the regs, etc. Pros and cons on each approach. 5/

But we don’t have good ways of evaluating different models in practice because we lack good measures of quality and effectiveness. Maybe for-profits are better. Maybe academic boards are better. Who knows what “better” even means here? 6/

In the paper we go through some of the senators’ requests and explain why they may not actually provide good insight because of other confounding factors and lack of specificity. 7/

Often when asked about quality, boards respond that they comply with the regs and point to all they do to make sure that happens. But given the discretion (appropriately) incorporated into the regs, compliance is not the same as participant protection, per se. 8/

So if you’re a board, you can focus on compliance and just ask if research is approvable on any plausible reading of the regs – or you can focus on ethics and ask if research *ought* to be approved, regardless of whether the regs would technically permit it. 9/

A focus on compliance only is likely to speed things up and may be most attractive to the purchasers of IRB services (which, of course, are not research participants). 10/

A focus on ethics can be a harder sell, but we explain why it may be easier (not easy) for academic boards to take this approach compared to other types of boards. 11/

We don’t mean to suggest that for-profit boards can’t aim for ethical practice. They can. But it has to be intentional and baked in. 12/

Will private equity ownership encourage that if owners come from business areas unfamiliar with the history of research ethics? If there is a responsibility to outside investors? If ethics doesn’t contribute to the bottom line? 13/

These are risk factors and they need safeguards. And to be fair, we note that traditional academic IRBs are not immune to pressures to speed reviews and other conflicts. 14/

Rather than using board type as a heuristic, it would be ideal to evaluate boards on the quality of their decisions. So we need to keep up with that work – as AEREO is. 15/

We are particularly interested in using precedent to flesh out the reasonableness of board activities and learning from the experiences of research participants. 16/

There’s also another interesting approach to consider. Could we merge the best features of local and for-profit boards: nonprofit status and institutional independence? 17/

This approach would reduce conflicts, make it easier to emphasize ethical review, and take advantage of business models that make review more efficient and potentially more expert. 18/

Nonprofit boards might also be more willing to share models, ideas, and data – and to try out new things in an experimental fashion. We can learn from this. 19/

The big question is whether they’d be viable in a market in which users might view them as more onerous. 20/

No board model is perfect – but their respective structures open them up to distinct challenges. We’d like to see all boards commit to emphasizing ethics above and beyond regulatory compliance and to adopt clear safeguards around conflicts of interest. 21/

I may the only one looking forward to a GAO investigation here but I think it’s a great step to renew attention to board quality and effectiveness and how best to promote it. 22/